(88 days)
K890328/B
Not Found
No
The device description focuses solely on the optical and mechanical aspects of the telescope, with no mention of AI, ML, image processing, or any data-driven features. The lack of information regarding training/test sets and performance metrics further supports this conclusion.
No.
The device description states that the telescopes are used as "optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures". The telescope assists in visualization during procedures, but it is the accessories used with the telescope that perform the therapeutic action.
Yes
The device description and intended use explicitly state that it is used in "diagnostic and surgical procedures" and for "endoscopic evaluation."
No
The device description explicitly states that the ACMI M4 Series Telescopes are "optical devices" and "rigid autoclavable optical instruments," indicating they are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic evaluation or for surgical procedures of the urological or gynecological systems." This involves direct visualization and intervention within the body.
- Device Description: The description confirms it's an "optical device" used with endoscopic accessories for "diagnostic and therapeutic procedures." It's designed for insertion into the body to visualize anatomy.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any analysis on biological samples.
Therefore, the ACMI M4 Series Telescopes are medical devices used for direct visualization and surgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.
Product codes
78 FBP
Device Description
ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems.
ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological or gynecological systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K890328/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® M4™ Telescope (Page 1 of 2)
General Information
Manufacturer:
ACMI Corporation 136 Turnpike Rd. Southborough, MA. 01772-2104
FDA Establishment Registration:
Contact Person:
2020483
Gabriel J. Muraca, Jr. Senior Regulatory Affairs Specialist
Date Prepared:
June 3, 2003
Device Description
Trade Name: ACMI® M4™ Series Telescopes
ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems.
Classification Names:
21CFR 876.1500 - Endoscope and accessories and 21 CFR 884.1690 - Hysteroscope and accessories
Generic/Common Name:
Telescopic system used along with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems.
Predicate Devices
ACMI Resectoscope System and accessories
K890328/B
Intended Uses
ACMI M4 Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.
1
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® M4™ Telescope (Page 2 of 2)
Product Description
ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.
Technological Characteristics and Substantial Equivalence
The M4 Series Telescopes are substantially equivalent to features incorporated in the M2 and M3 telescopes, as described in K890328/B, the ACMI Resectoscope System and accessories. The M2 and M3 telescopes are legally marketed predicate devices. The M4 Series designs utilize similar telescope technology (design, materials, and performance specifications) as in the predicate devices and, therefore, are substantially equivalent to the ACMI M2 and M3 series telescopes.
Summary of Safety and Effectiveness
This 510(k) proposes several modifications in materials, design, and the manufacturing process for the M4 Series telescopes. The indications for use and principles of operation remain the same as in the predicate devices. The proposed modifications for the M4 Series Telescopes, as described in this submission, are substantially equivalent to the predicate devices. The proposed modification in materials, design, and processing are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
In summary, ACMI believes the ACMI M4 Series telescopes are substantially equivalent to the predicate devices, because they have the same intended use and similar technological characteristics.
2
Image /page/2/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "Department of Health & Human Services" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2003
Mr. Gabriel J. Muraca, Jr., RAC Senior Regulatory Affairs Specialist ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104 Re: K031758 Trade/Device Name: ACMI® M4TM Telescopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBP Dated: June 3, 2003 Received: June 6, 2003
Dear Mr. Muraca:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name: ACMI® M4™ Telescope
510(k) Number: Ko31758
Indications for Use:
ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ X __
OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Nancy Brodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031758